NDC 58668-3330 Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene

NDC Product Code 58668-3330

NDC Code: 58668-3330

Proprietary Name: Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58668 - Laboratoires Clarins
    • 58668-3330 - Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort

NDC 58668-3330-0

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 150 mL in 1 BOTTLE, SPRAY

NDC 58668-3330-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 150 mL in 1 BOTTLE, SPRAY

NDC Product Information

Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort with NDC 58668-3330 is a a human over the counter drug product labeled by Laboratoires Clarins. The generic name of Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort is avobenzone, homosalate, octinoxate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Laboratoires Clarins

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 30 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 100 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
  • POLYESTER-7 (UNII: 0841698D2F)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • POLYSILICONE-15 (UNII: F8DRP5BB29)
  • MANNITOL (UNII: 3OWL53L36A)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PEA (UNII: W4X7H8GYFM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires Clarins
Labeler Code: 58668
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort Product Label Images

Clarins Broad Spectrum Spf 50 Sunscreen Body Hydration, Comfort Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

AVOBENZONE 3%HOMOSALATE 10%OCTINOXATE 7.5%OCTISALATE 5%OCTOCRYLENE 10%

Purpose

Sunscreen

Uses:

• helps prevent sunburn


• if used as directed with other sun protection measures (see


Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do Not Use

On damaged or broken skin.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

Rash occurs.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• apply liberally 15 minutes before sun exposure


• apply to all skin exposed to the sun


• children under 6 months: Ask a doctor





Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:


• limit time in the sun, especially from 10 a.m. – 2 p.m.


• wear long-sleeved shirts, pants, hats and sunglasses


• reapply at least every 2 hours


• use a water resistant sunscreen if swimming or sweating

Other Information:

• protect this product from excessive heat and direct sun

Inactive Ingredients

AQUA/WATER/EAU . BUTYLOCTYL SALICYLATE . STYRENE/ACRYLATES COPOLYMER . BUTYLENE GLYCOL . POLYGLYCERYL-6 STEARATE . POLYESTER-7 . NEOPENTYL GLYCOL DIHEPTANOATE . ALOE BARBADENSIS LEAF JUICE . DIETHYLHEXYL SYRINGYLIDENEMALONATE . PARFUM/FRAGRANCE . POLYSILICONE-15 . MANNITOL . POTASSIUM CETYL PHOSPHATE . PHENOXYETHANOL . PEG-8 LAURATE . DIMETHICONE . GLYCERIN . POLYGLYCERYL- 6 BEHENATE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . POLYACRYLATE CROSSPOLYMER-6 . SODIUM DEHYDROACETATE . CAPRYLIC/CAPRIC TRIGLYCERIDE . TOCOPHEROL . DIMETHICONOL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . BHT . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . T-BUTYL ALCOHOL . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S2031C]

* Please review the disclaimer below.

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